At a glance
ClinicalIndex Comparison Record- ✓Confirmed clinical and laboratory diagnosis of hereditary angioedema (HAE)
- ✓Plasma functional C1 inhibitor level less than 50% of normal
- ✓Acute HAE attack involving abdomen, urogenital tract, peripheral areas, or face/throat/airway
- ✕Acquired angioedema (as opposed to hereditary)
- ✕Pregnancy or breastfeeding
- ✕Any investigational drug use within 30 days prior to enrollment
- ✕Body weight exceeding 120 kg
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-controlled, Double Blind Phase II/III Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
In Brief
A Phase 3 clinical trial evaluating Recombinant Human C1 Inhibitor and placebo for Hereditary Angioedema and Angioneurotic Edema. Completed, enrolled 77 participants across 1 site.
Detailed Summary
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that lead to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks. Funding Source - FDA OOPD
Study Details
Timeline
Interventions
IV
saline solution